Failure to warn

The U.S. Supreme Court settled a major liability issue in Wyeth v. Levine this week.

A patient was given an IV push dose of Phenergan, apparently the administration was done in a negligent manner and the medicine entered an artery, and the patient lost her arm.

As best I can tell there was no allegation that Phenergan, a widely used drug, was hazardous, but that the drug maker Wyeth should have provided better warnings about what could happen if an IV push administration was done improperly.

(I checked with my favorite nurse, who tells me that she doesn't need to be warned not to put an IV into an artery, as she said "what do you think the "V" stands for." Nurses rarely read warning materials on commonly used drugs anyway. Just one opinion. She does administer Phenergan regularly, although not via IV.)

The legal argument?

Wyeth claimed that since the FDA had found Phenergan to be safe and effective, and because the FDA has approved very precise language on the label, there was no duty to provide further warnings and no ability to unilaterally rewrite the warning materials.

SCOTUS says the state could find a duty and that Wyeth could have unilaterally changed the labeling.

So what does label approval by the FDA mean today? How far does the unilateral rewrite authority go? What if the FDA disagrees with the unilateral rewrite.

From a liability standpoint, how much liability should a drug or device maker have for provider malpractice?

Interesting questions.